The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.

Abstract

The German government initiated the Network University Medicine (NUM) in early 2020 to improve national research activities on the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic. To this end, 36 German Academic Medical Centers started to collaborate on 13 projects, with the largest being the National Pandemic Cohort Network (NAPKON). The NAPKON’s goal is creating the most comprehensive Coronavirus Disease 2019 (COVID-19) cohort in Germany. Within NAPKON, adult and pediatric patients are observed in three complementary cohort platforms (Cross-Sectoral, High-Resolution and Population-Based) from the initial infection until up to three years of follow-up. Study procedures comprise comprehensive clinical and imaging diagnostics, quality-of-life assessment, patient-reported outcomes and biosampling. The three cohort platforms build on four infrastructure core units (Interaction, Biosampling, Epidemiology, and Integration) and collaborations with NUM projects. Key components of the data capture, regulatory, and data privacy are based on the German Centre for Cardiovascular Research. By December 01, 2021, 34 university and 34 non-university hospitals have enrolled 4,241 patients with local data quality reviews performed on 2,812 (66%). 47% were female, the median age was 53 (IQR: 38-63)) and 3 pediatric cases were included. 30% of patients were hospitalized, 11% admitted to an intensive care unit, and 4% of patients deceased while enrolled. 7,143 visits with biosampling in 3,595 patients were conducted by November 29, 2021. In this overview article, we summarize NAPKON’s design, relevant milestones including first study population characteristics, and outline the potential of NAPKON for German and international research activities.Trial registration:· https://clinicaltrials.gov/ct2/show/NCT04768998· https://clinicaltrials.gov/ct2/show/NCT04747366· https://clinicaltrials.gov/ct2/show/NCT04679584

Fatigue and cognitive impairment after COVID-19: A prospective multicentre study

“…The population-based NAPKON cohort is representative of the background population in all major sociodemographic characteristics 15 and the proportion of hospitalised patients in our sample (6%) parallels the hospitalization rate in Germany during the study period. 46 Additional strengths of our study include the well-matched control group, use of validated instruments and detailed data on sociodemographic and clinical characteristics, comorbidity, blood tests and psychiatric symptoms.…”

“…COVIDOM is a population-based, prospective multicentre study in the German National Pandemic Cohort Network (NAPKON). 15 , 16 Patient inclusion criteria were: (i) a positive polymerase chain reaction (PCR) test for SARS-CoV-2, (ii) a primary residence in in the administrative regions of Schleswig-Holstein or Würzburg, and (iii) age ≥18 years at the time of infection. Patients were invited by mail through public health authorities.…”

“…by age group), based on prior effect-size estimates. 15 , 17 Accordingly, 1000 cases with complete data on the Montreal Cognitive Assessment (MoCA) and the FACIT-Fatigue questionnaire were randomly selected. To rule out non-wild-type variants of SARS-CoV-2, this analysis includes only participants with initial PCR before February 14, 2021.…”

Post-COVID: Alles eine Frage der Definition?

“…Ein weiterer wichtiger Aspekt ist die Komplexität der Abbildung einer solch weiten Definition in großen Kohortenstudien, wie beispielsweise im Nationalen Pandemie-Kohorten-Netzwerk (NAP-KON), einem Projekt im Rahmen des NUMs [39,40] Merke Für aktuelle und zukünftige Forschungsfragen sollten die Kriterien, die Patient*innen mit langfristigen Symptomen charakterisieren, objektiviert werden, indem standardisierte Fragebögen, die alle Aspekte des biopsychosozialen Modells abbilden, genutzt werden und auch funktionelle Einschränkungen mit erfassen. Neben Aktivitätstest wie dem häufig genutzten 6-Minuten-Gehtest, ist auch die Post-COVID-Functional-Scale eine praxisorientierte Möglichkeit [16,36].…”

Statistical biases due to anonymization evaluated in an open clinical dataset from COVID-19 patients

“…On 15th of March 2022, worldwide, more than 460 million infected cases have been detected and more than 6 million people have died as a result of the Coronavirus Disease 2019 (COVID-19, https://covid19.who.int/). In order to collect high-quality clinical data, image data and biosamples of COVID-19 patients in Germany, the National Pandemic Cohort Network (NAPKON) was founded in 2020 as part of the Network University Medicine (NUM), a state-funded network to tackle the COVID-19 pandemic in Germany 4 . NAPKON consists of three sub-cohorts, which differ in granularity, severity of disease and sector of recruitment (Cross-Sectoral Platform (SUEP), High-Resolution Platform (HAP), and Population-Based Platform (POP)).…”